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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, cranial
510(k) Number K022273
Device Name CRANIAL SYMMETRY SYSTEM
Applicant
BEVERLY HILLS PROSTHETICS ORTHOTICS, INC.
6300 WILSHIRE BLVD., SUITE 150
LOS ANGELES,  CA  90048 -5203
Applicant Contact KEITH E VINNECOUR
Correspondent
BEVERLY HILLS PROSTHETICS ORTHOTICS, INC.
6300 WILSHIRE BLVD., SUITE 150
LOS ANGELES,  CA  90048 -5203
Correspondent Contact KEITH E VINNECOUR
Regulation Number882.5970
Classification Product Code
MVA  
Date Received07/15/2002
Decision Date 09/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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